Initial Results: A laboratory performed routine calibration verification / linearity testing using VALIDATE® GC 4. Results for both Total Bilirubin and Direct Bilirubin were well below the upper range of the method, and were visually nonlinear. The following was the TBIL report generated for using MSDRx®, the Maine Standards Data Reduction software:
The laboratory contacted Maine Standards Company Technical Support. Technical Support advised the laboratory that the results were not consistent with Peers and that the curve was typical of product that was not stored properly. The proper storage conditions for VALIDATE® GC 4 is
-10 to -25°C in a non-frost free freezer. More details regarding the need for non-frost-free freezers are provided in Technical Service Bulletin 05-001.
Troubleshooting: The laboratory took the troubleshooting step of reordering a fresh kit of GC 4 and rerunning the calibration verification / linearity experiment. The updated MSDRx® report for TBIL shows that all Levels are within the statistical limits. The laboratory accepted the updated results and determined that they had validated the linearity across the reportable range of the method.
Summary: Maine Standards Company Technical Support advised that recovery was not consistent with Peers. In this case, improper storage damaged the VALIDATE® test set. This case study emphasizes the need to store products per the manufacturer's instructions. Storage requirements for VALIDATE® products are printed on the kit boxes, bottle labels and in the package inserts.
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